MAUDE manufacturer profile

VYGON USA · FOS

MAUDE profile for Catheter, Umbilical Artery

Key facts

Manufacturer VYGON USA
Manufacturer group VYGON
Product code FOS
Product code name Catheter, Umbilical Artery

At a glance

  • 100–999 MAUDE reports
  • 1–9 Death reports
  • 10–99 Injury reports
  • 10–99 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Fluid/Blood Leak, Break, No Clinical Signs, Symptoms or Conditions, Material Fragmentation, Device Embedded In Tissue or Plaque, No Information, Foreign Body In Patient, Malposition of Device Most reported problems

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About MAUDE manufacturer and product code profiles

Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.

Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1

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